LOSEC 40MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance: OMEPRAZOLE SODIUM FOR INJECTION

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PS01699

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losec 40 mg powder and solvent for solution
for injection
Omeprazole
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.
In this leaflet:
1. What Losec is and what it is used for
2. Before Losec is given to you
3. How Losec is given to you
4. Possible side effects
5. How to store Losec
6. Further information
1. WHAT LOSEC IS AND WHAT IT IS USED FOR
Losec contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump
inhibitors’. They work by reducing the amount of acid that your stomach produces.
Losec powder and solvent for solution for injection can be used as an alternative to oral therapy.
2. BEFORE LOSEC IS GIVEN TO YOU
You must not be given Losec
• If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Losec.
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole,
esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infection).
If you are not sure, talk to your doctor, nurse or pharmacist before you are given this medicine.
Take special care with Losec
Losec may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you
are given Losec or after you are given it, talk to your doctor straight away:
• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase
in infectious diarrhoea.
• You have severe liver problems.
Taking a proton pump inhibitor like Losec, especially over a period of more than one year, may slightly
increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are
taking corticosteroids (which can increase the risk of osteoporosis).
Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is because Losec can affect the way some
medicines work and some medicines can have an effect on Losec.
You must not be given Losec if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you
start or stop taking Losec.
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may
need to monitor you when you start or stop taking Losec.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of organ transplantation).
• St John’s wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high
dose of methotrexate, your doctor may temporarily stop your Losec treatment.
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Losec to treat ulcers
caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines
you are taking.
Pregnancy and breast-feeding
Before you are given Losec, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will
decide whether you can be given Losec during this time.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are
used. Your doctor will decide whether you can take Losec if you are breastfeeding.
Driving and using machines
Losec is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness
and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
3. HOW LOSEC IS GIVEN TO YOU
• Losec can be given to adults including the elderly.
• There is limited experience with Losec for intravenous use in children.
Being given Losec
• Losec will be given to you by a doctor who will decide how much you need.
• The medicine will be given to you as an injection into one of your veins.
If you are given more Losec than you should
If you think you have been given too much Losec, talk to your doctor straight away.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Losec can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop using Losec and contact a
doctor immediately:
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow
(severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips,
eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may occur with certain frequencies, which are defined as follows:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000 
affects less than 1 user in 10,000
frequency cannot be estimated from the available data.

Other side effects include:
Common side effects
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.

Rare side effects
• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising
or make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.
Very rare side effects
• Changes in blood count including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and
joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlarged breasts in men.
Not known
• Inflammation in the gut (leading to diarrhoea).
• If you are on Losec for more than three months it is possible that the levels of magnesium in your blood
may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation,
convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor
promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the
blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received
Losec intravenous injection, especially at high doses, but no causal relationship has been established.
Losec may in very rare cases affect the white blood cells leading to immune deficiency. If you have an
infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of
a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your
doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood
test. It is important for you to give information about your medicine at this time.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects
get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LOSEC
• Keep out of the reach and sight of children.
• Do not use Losec after the expiry date which is stated on the label and carton after EXP. The expiry date
refers to the last day of that month.
• Do not store above 25°C. Store in the original package in order to protect from light.
• Shelf life after reconstitution:
The reconstituted solution should not be stored at temperatures above 25°C and should be used within
4 hours after preparation. From a microbiological point of view, the product should be used immediately
unless it has been reconstituted under controlled and validated aseptic conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Losec contains
• The active substance is omeprazole. Each vial of powder for solution for injection contains omeprazole
sodium equivalent to 40 mg of omeprazole.
• The other ingredients are:
Powder for injection: Sodium hydroxide (for pH adjustment).
Solvent for injection: Citric acid monohydrate (for pH adjustment), macrogol 400, and water for injections.
What Losec looks like and contents of the pack
Losec 40 mg powder and solvent for solution for injection (Powder for injection; and Solvent for
reconstitution of solution for injection) comes in a combination pack consisting of a vial containing dry
substance (I) and an ampoule containing solvent (II).
The dry powder in the vial is made into a solution before it is given to you.
Pack sizes: 1x40 mg(I+II), 5x40 mg(I+II), 10x40 mg (I+II).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Losec Injection is held by AstraZeneca UK Limited, 600 Capability Green,
Luton LU1 3LU, United Kingdom.
Losec Injection and solvent are manufactured by AstraZeneca AB, S‑151 85, Södertälje, Sweden.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Losec
Denmark: Losec
Greece: Losec
Netherlands: Losec
Portugal: Losec
Sweden: Losec
UK: Losec

To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name:
Losec IV Injection 40 mg
Reference number: 17901/0135
This is a service provided by the Royal National Institute of Blind People.
Leaflet last updated: December 2012
© AstraZeneca 2012
Losec is a trade mark of the AstraZeneca group of companies.
GI 12 0187
----------------------------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Losec solution for injection is obtained by dissolving the freeze-dried substance in the accompanying
solvent. No other solvent should be used.
The stability of omeprazole is influenced by the pH of the solution for injection, which is why no other solvents
or quantities should be used for dilution. Improperly prepared solutions can be identified by their yellow to
brown discolouration and must not be used. Use only clear, colourless or pale yellowish-brown solutions.
Preparation
NOTE: Steps 1 to 5 must be performed in immediate sequence:
1. With a syringe draw all of the solvent from the ampoule (10 ml).
2. Add approximately 5 ml of the solvent to the vial with freeze-dried omeprazole.
3. Withdraw as much air as possible from the vial back into the syringe. This will make it easier to add the
remaining solvent.
4. Add the remaining solvent into the vial, make sure the syringe is empty.
5. Rotate and shake the vial to ensure all the freeze-dried omeprazole has dissolved.
Losec solution for injection must be given only as an intravenous injection and it must not be added
to infusion solutions. After reconstitution the injection should be given slowly over a period of at least
2.5 minutes at a maximum rate of 4 ml per minute.
GI 12 0187

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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